Dr. Cone added, "I support the efforts of the FDA in their efforts to transition from non-abuse deterrent formulations to AD formulations of opioids. We have seen the promise of these products in reducing abuse rates in the community and in reducing adverse outcomes. However, there remains considerable work to be done. Our proprietary ALERRT® system quantifies the "degree of effort" involved in tampering of drug products, including abuse-deterrent formulations of opioids. Data from the ALERRT system can help sponsors select formulations with the most robust abuse-deterrent properties in early development efforts, which can help to ensure that new drugs coming to market will be of most benefit to public health."
PinneyAssociates, a pharmaceutical and consumer healthcare consulting company that helps clients to reduce their regulatory risk and enhance the commercial value of their life sciences products. PinneyAssociates consults with pharmaceutical companies that market a wide variety of prescription and over-the-counter medications. PinneyAssociates' experts have extensive expertise in abuse-deterrent drug formulation evaluation, abuse potential assessment, as well as pharmaceutical risk management, Rx-to-OTC switch, and tobacco harm reduction.
For more information about PinneyAssociates, please contact us at +1.301.718.8440 or email@example.com, or learn more about our work at www.pinneyassociates.com.
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